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NCT00640692 Clinical Trial

Kinase Genotyping of Gastro Intestinal Stomach Tumors (GISTs) From Patients Enrolled in Pfizer A6181112 Phase IIIb Trial

Gastrointestinal Neoplasm Clinical Trial

Official title:
Kinase Genotyping of Gastrointestinal Stromal Tumors (GIST) From Patients Enrolled in the A6181112 Phase IIIb Trial at Participating U.S. and Ex-U.S. Medical Centers

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00640692
Other study ID # Pfizer GIST Genotyping Study
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date December 2007
Est. completion date April 2011

Study information
Verified date October 2019
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine the genetic makeup of gastro intestinal stomach tumors (GISTs) from patients enrolled in the A6181112 phase IIIb trial. Tumor samples will be screened for mutations and this information will be used to determine whether the progression-free survival of patients being treated with the cancer medication sunitinib is related to the underlying genotype of their GIST.

Description:

In this companion study, we will analyze the genomic DNA from the GIST tumor specimens of patients enrolled in the in the A6181112 phase IIIb trial at participating U.S. and ex-U.S. medical centers. Specifically, GIST samples will be screened for mutations in KIT gene exons 9, 11, 13 and 17, and PDGFRA gene exons 12, 14 and 18, to determine the primary kinase genotype. Subset analyses will be performed and compared with the overall PFS rates observed in patients with primary and secondary imatinib resistance. Based on data from a previous phase I/II trial, our hypothesis is that patients with either primary or secondary imatinib resistance having a KIT exon 9-mutant or WT GIST will have a longer PFS when treated with sunitinib than patients with exon 11-mutant GIST. We further hypothesize that this difference will be observed among patients treated with high-dose imatinib.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2011
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients enrolled in Pfizer A6181112

Exclusion Criteria:

- Patients who do not consent for analysis of their tumor in this companion study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Oregon Health and Science University Pfizer
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